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AirKEE T900 is a medical ultraviolet air purifier intended for medical purposes to capture and destroy bacterial, mold, and viruses in the air through the multi-stage air filtration system and exposure to ultraviolet radiation.

AirKEE T900 has been demonstrated to eliminate the following test microorganisms entrained on the subject device under the following exposure conditions:

AirKEE T900 is a mobile medical ultraviolet air purifier. It is used to destroy bacteria in the air by exposure to ultraviolet radiation. It may be used for medical purposes which can include hospitals, medical facilities, medical clinics, nursing facilities, and dental facilities. AirKEE T900 is controlled via a touchscreen control panel on the machine.

AirKEE T900's main components consist of:
Multi-stage air treatment

• a filtration system with primary filter, medium efficiency filter, HEPA filter, activated O carbon filter, and nano-material filter
• UV lamps that generate UV-C irradiation to eliminate microorganisms о
• o a motor/impeller to move air through the filtration system

System control

• o an electronic control system to power and control the device
• a touch panel interface to indicate the working status of the device and consumables O

AirKEE T900's multi-stage air treatment: Air enters through the bottommost chamber and passes through primary G4 filter, where large particulate matter will be removed. G4 filtered air then passes through modified activated carbon and patented nano-material filter for further removal. Microorganisms will be inactivated by UV, and photocatalysts. Lastly, HEPA H14 filter eliminates 99.99% of the remaining particles (0.1 microns in diameter). The treated air then exits through the top of the machine.

The touch panel allows reading, troubleshooting functions, and settings of various function. Its enhanced user interface with touchscreen function allows easier navigation of the system.

The provided FDA 510(k) notification describes the AirKEE T900, a medical ultraviolet air purifier, and its performance. It outlines the device's indications for use and presents a summary of non-clinical tests to demonstrate its effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

• Staphylococcus albus: Log 4 (99.99%) reduction in 60 minutes at high fan speed; Log 4 (99.99%) in 120 minutes at low fan speed
• Escherichia coli: Log 4 (99.99%) reduction in 60 minutes at high fan speed; Log 4 (99.99%) in 120 minutes at low fan speed
  Mold:
• Penicillium rocqueforti: Log 4 (99.99%) reduction in 60 minutes at high fan speed
• Aspergillus Niger: Log 4 (99.99%) reduction in 120 minutes at low fan speed
  Virus:
• Influenza A virus, H1N1: Log 4 (99.99%) reduction in 60 minutes at high fan speed
• Influenza A virus, H3N2: Log 4 (99.99%) reduction in 120 minutes at low fan speed |
  | Fractional Efficiency | Per Standard particles | Filter fractional efficiency percentage of 99.99% at 0.1-0.2µm |
  | Electrical Safety and EMC | Per Standard | Pass |
  | Ozone | Per Standard (less than 0.05 ppm) | Testing demonstrates the AirKEE T900 unit is able to operate at less than 0.05 ppm at its highest fan speed. |

Note: The term "acceptance criteria" is derived directly from the "Acceptance Criteria" column in the provided table.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample size for the test set in terms of the number of individual devices tested or the number of replicates for each microbiological test. The provenance of the data is not explicitly stated in terms of country of origin or whether the studies were retrospective or prospective, beyond "Internal Standards" for microorganism performance. These are non-clinical laboratory tests.

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

This document describes non-clinical performance testing of a physical device (air purifier) for its ability to filter and destroy microorganisms and to meet safety standards. It does not involve interpretation of medical images or diagnostic outputs that would typically require human experts to establish "ground truth" in the context of an AI/human reader study. Therefore, the concepts of "number of experts" and "qualifications of those experts" are not applicable to the studies described.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are relevant for studies involving human interpretation or subjective assessments, typically in diagnostic or imaging contexts. Since the described studies are non-clinical laboratory performance tests (e.g., measuring log reduction of microorganisms, filter efficiency, electrical safety), adjudication methods are not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for AI-assisted diagnostic devices where the AI's impact on human reader performance is evaluated. The AirKEE T900 is an air purification device, and its performance is assessed through laboratory-based efficacy and safety tests, not through human reader interpretation of data or images.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

Yes, the studies described are essentially "standalone" performance evaluations of the device itself, without human-in-the-loop interaction in the context of a diagnostic or interpretive task. The performance metrics (e.g., log reduction of microorganisms, filter efficiency, ozone levels) are direct measurements of the device's function.

7. The Type of Ground Truth Used

The ground truth for the performance evaluations is established through:

• Quantitative Microbiological Assays: For microorganism performance, the "ground truth" is the measured reduction in viable microorganisms (bacteria, mold, viruses) under specific test conditions. This is an objective, laboratory-derived measurement.
• Physical Measurements and Engineering Standards: For fractional efficiency, electrical safety, and ozone release, the "ground truth" is defined by adherence to established industry standards (IEST-RP-CC001.6, UL 507, IEC 60601-1-2, UL 867) and direct physical measurements confirming compliance.

8. The Sample Size for the Training Set

This document details non-clinical performance and safety testing of a manufactured device, not a machine learning or artificial intelligence (AI) algorithm. Therefore, the concept of a "training set sample size" is not applicable, as there is no AI model being trained.

9. How the Ground Truth for the Training Set was Established

As noted above, this pertains to a physical medical device, not an AI model. Therefore, the concept of a "training set" and "established ground truth for the training set" is not relevant to this submission. The device's performance is based on its physical and functional design, which is validated through the non-clinical tests described.

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